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临床试验/NCT06515600
NCT06515600尚未招募不适用

Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?

South Valley University0 个研究点目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Blood Pressure mmHg

研究概览

简要总结

The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).

详细描述

The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).1. Flow Trigger: This type of trigger responds to the gas flow during inspiration. A flow trigger measures the rate of change of flow as the patient begins to inhale. When the flow reaches a certain threshold, the ventilator is triggered to deliver a breath.

  1. Laboratory investigations: Arterial blood gases (ABG):- (PH, PCO2, HCO3, and PO2) after the session.
  2. Ventilator Parameters:( a) Minute Ventilation, b) Tidal Volume, c) Rapid Shallow breathing index, d) Negative Inspiratory Force (NIF) will be measured pre and post-treatment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Our Study was performed on sixty patients with VIDD from both genders. All patients will be referred by a physician. All patients were randomly assigned into two groups equal in number

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age (years)
  • •Weight (kg)
  • •Height (cm)
  • •BMI (kg/m²)
  • •Inclusion Criteria:
  • •Patients who had undergone MV for 48 hours or more in a controlled mode.
  • •Patients could not generate maximum inspiratory pressure of more than 15 mbar
  • •Patients had diaphragmatic excursion less than 3 cm. (normal level from 3 to 5 cm.)(It can increase in a condition person to 7-8 cm).
  • •Patients had a diaphragmatic thickness fraction of less than 30%

排除标准

  • •Patients with comorbidities interfering and compromising weaning like cardiac arrhythmia, pericardial effusion, congestive heart failure, or unstable acute coronary syndrome.
  • •Patients who had inadequate training performance of the inspiratory muscle such as those having myopathy or neuropathy.
  • •Patients hemodynamically unstable.
  • •Patients who had a major neurological deficit.
  • •Sedated Patients.

研究组 & 干预措施

Study group

Experimental

Group (A) (study group) will include 30 patients who practiced flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.

干预措施: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. (Device)

Controlled group

Active Comparator

Group (B) (controlled group) will include 30 patients who received their routine plan of weaning of mechanical ventilator (controlled mode then spontaneous mode and finally spontaneous breathing trial).

干预措施: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. (Device)

结局指标

主要结局

Blood Pressure mmHg

时间窗: one week

Blood Pressure mmHg

HCO3 mEQ/Liter

时间窗: one week

HCO3 mEQ/Liter

Arterial blood gases (ABG):-

时间窗: one week

PH

PCO2 mmHg

时间窗: one week

PCO2 mmHg

PSAO2 mmHg

时间窗: one week

PSAO2 mmHg

Vital signs

时间窗: one week

Heart Rate (HR) b/min

Respiratory rate RR/min

时间窗: one week

Respiratory rate RR/min

次要结局

  • Tidal Volume L/breath(one week)
  • Ventilator parameters(one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Abuzaid

Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

South Valley University

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